dinox consultancy advises on product development, study design, data interpretation and other issues in female health research, and on issues concerning the female population in clinical studies in general. Additionally, medical writing services and training sessions are provided.
The physicians at dinox have more than 25 years of experience in the conduct of clinical studies in the female population. They have gained extensive knowledge of gynaecological endocrinology and of compounds registered in this field. They have access to a well-established network of experts in all areas of drug development from the preclinical phase until post-registration marketing.
Based upon their experience and knowledge, dinox consultancy advises on
- product development in female health research
- study design development and optimalisation
- research protocol and other trial documents
- choice of pharmacodynamic parameters
- data interpretation
- scientific issues in the area of gynaecological endocrinology and female sexual health
- issues concerning the female population in clinical studies in general, e.g.
- logistics of cycle-dependent study drug administration and assessments
- contraception in clinical studies
- emergency measures in cases of failed contraception
- recruitment strategies
- optimalisation of trial logistics
- optimalisation of company processes in clinical research
- reply to questions by the authorities
- preparation of authority audits
dinox consultancy provides medical writing services:
- protocol writing
- writing of informed consent form
- writing of scientific publications
dinox consultancy provides training sessions on
- women in clinical trials: guidelines, background, characterization of fertility status, implementing the guidelines in practice, challenges in practice
- interaction studies with oral contraceptives: background, design, interpretation
- contraceptive use during the conduct of clinical trials
- biomarkers for the contraceptive effect
- study design for the development of hormonal contraceptives
Other topics can be addressed upon request.